Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
J Cardiovasc Electrophysiol. 2019 Oct;30(10):1841-1847. doi: 10.1111/jce.14080. Epub 2019 Aug 4.
The utility of pressure waveform analyses to assess pulmonary vein (PV) occlusions has been reported in cryoballoon PV isolation (CB-PVI) using first-generation CBs. This prospective randomized study compared the procedural and clinical outcomes of pressure-guided and conventional CB-PVI.
Sixty patients with paroxysmal atrial fibrillation underwent CB-PVI with 28-mm second-generation CBs. PV occlusions were assessed either by real-time pressure waveforms without contrast utilization (pressure-guided group) or contrast injections (conventional group) and randomly assigned. Before the randomization, 24 patients underwent pressure-guided CB-PVIs. In the derivation study, a vein occlusion was obtained in 88/96 (91.7%) PVs among which 86 (97.7%) were successfully isolated by the application. In the validation study, the nadir balloon temperature and total freezing time did not significantly differ per PV between the two groups. The positive predictive value of the vein occlusion for predicting successful acute isolations was similar (93 of 103 [90.2%] and 89 of 98 [90.8%] PVs; P = 1.000), but the negative predictive value was significantly higher in pressure-guided than angiographical occlusions (14 of 17 [82.3%] vs 7 of 22 [31.8%]; P = .003). Both the procedure (57.7 ± 14.2 vs 62.6 ± 15.8 minutes; P = .526) and fluoroscopic times (16.3 ± 6.4 vs 20.1 ± 6.1; P = .732) were similar between the two groups, however, the fluoroscopy dose (130.6 ± 97.7 vs 353.2 ± 231.4 mGy; P < .001) and contrast volume used (0 vs 17.5 ± 7.7 mL; P < .001) were significantly smaller in the pressure-guided than conventional group. During 27.8 (5-39) months of follow-up, the single procedure arrhythmia freedom was similar between the two groups (P = .438).
Pressure-guided second-generation CB-PVIs were similarly effective and as safe as conventional CB-PVIs. This technique required no contrast utilization and significantly reduced radiation exposure more than conventional CB-PVIs.
在使用第一代冷冻球囊进行冷冻球囊肺静脉隔离（CB-PVI）时，已有研究报道了压力波形分析在评估肺静脉（PV）闭塞方面的应用。本前瞻性随机研究比较了压力引导与常规 CB-PVI 的手术和临床结局。
60 例阵发性心房颤动患者接受了 28-mm 第二代冷冻球囊的 CB-PVI。通过不使用对比剂（压力引导组）或注射对比剂（常规组）实时评估 PV 闭塞，并进行随机分组。在随机分组前，24 例患者进行了压力引导的 CB-PVI。在推导研究中，96 个 PV 中有 88 个（91.7%）获得了静脉闭塞，其中 86 个（97.7%）通过应用成功隔离。在验证研究中，两组每个 PV 的球囊最低温度和总冷冻时间无显著差异。静脉闭塞对预测急性隔离成功的阳性预测值相似（103 个 PV 中有 93 个[90.2%]和 98 个 PV 中有 89 个[90.8%]；P=1.000），但压力引导下的阴性预测值明显高于血管造影下的阴性预测值（17 个 PV 中有 14 个[82.3%]和 22 个 PV 中有 7 个[31.8%]；P=0.003）。两组的手术时间（57.7±14.2 分钟与 62.6±15.8 分钟；P=0.526）和透视时间（16.3±6.4 分钟与 20.1±6.1 分钟；P=0.732）相似，但压力引导组的透视剂量（130.6±97.7 毫戈瑞与 353.2±231.4 毫戈瑞；P<0.001）和使用的造影剂体积（0 毫升与 17.5±7.7 毫升；P<0.001）明显小于常规组。在 27.8（5-39）个月的随访中，两组单次手术心律失常无差异（P=0.438）。
与常规 CB-PVI 相比，压力引导第二代冷冻球囊的 PV 隔离同样有效且安全。该技术无需使用对比剂，与常规 CB-PVI 相比，显著减少了辐射暴露。
